An Observational, Cross Sectional Study to Assess the Prevalence of Chronic Kidney Disease (CKD) in Type 2 Diabetes Patients (START-INDIA)

March 24, 2016 updated by: AstraZeneca

An Observational, Cross Sectional Study to Assess the Prevalence of Chronic Kidney Disease in Type 2 Diabetes Patients in India

This non-interventional, multi-centric, cross-sectional study is aimed to determine the prevalence of Chronic Kidney Disease in Indian patients with Type 2 Diabetes (T2DM). 3000 patients will be enrolled from 30 investigative sites all over the country. Each investigative site will be expected to enrol 100 subjects. All the procedures will be completed in a single day.

Study Overview

Status

Completed

Conditions

Detailed Description

This is an observational, multicenter, cross-sectional study to be conducted at 30 sites in India. Endocrinologist/ Diabetologist from multiple private clinics will evaluate the Type 2 Diabetes patients. The study will be conducted over 9-10 months and will be started after obtaining written approval of Independent Ethics Committee (IEC) and written Informed consent of the patient. . Each investigative site will be expected to enrol 100 subjects. All the procedures will be completed in a single day.

Study Type

Observational

Enrollment (Actual)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Ahmedabad, India
        • Research Site
      • Bangalore, India
        • Research Site
      • Chandigarh, India
        • Research Site
      • Chennai, India
        • Research Site
      • Coimbatore, India
        • Research Site
      • Delhi, India
        • Research Site
      • Ghaziabad, India
        • Research Site
      • Hyderabad, India
        • Research Site
      • Jaipur, India
        • Research Site
      • Kanpur, India
        • Research Site
      • Karnal, India
        • Research Site
      • Kolkata, India
        • Research Site
      • Ludhiana, India
        • Research Site
      • Mumbai, India
        • Research Site
      • Noida, India
        • Research Site
      • Pune, India
        • Research Site
      • Rohtak, India
        • Research Site
      • Trivandrum, India
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A total of 3000 T2DM patients of either gender with age of 18 years and more will be enrolled in the study after the Informed Consent Process.

Description

Inclusion Criteria:

  1. Known cases of T2DM.
  2. Male and female patients aged 18 years and above.
  3. Must provide written Informed consent.

Exclusion Criteria:

  1. Patients with known type-1 diabetes.
  2. Patients with any form of acute kidney injury based on investigator's discretion.
  3. Patients on maintenance dialysis or known renal transplant patients.
  4. Patients who have participated in any interventional study within past 3 months prior to entry in this study.
  5. Pregnant women.
  6. Patients with symptomatic Urinary Tract Infection (UTI) or with history of hematuria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
T2DM patients with Chronic Kidney Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of T2DM patients with Chronic Kidney Disease (CKD)
Time Frame: 1 day
The proportion of T2DM patients with CKD as per GFR (Glomerular Filtration Rate)criteria. GFR below 90 ml/min/1.73 m2 is defined as CKD. we will also classify CKD into various groups as per the KDIGO 2013.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of T2DM patients in various stages of CKD
Time Frame: 1 day
The proportion of T2DM patients with CKD as per GFR (Glomerular Filtration Rate)criteria. We will also classify CKD into various groups as per the KDIGO (KIDNEY DISEASE IMPROVING GLOBAL OUTCOMES) 2013.
1 day
Frequency of T2DM patients with CKD in patients with different duration of T2DM
Time Frame: 1 day
The proportion of T2DM patients with CKD as per GFR (Glomerular Filtration Rate)criteria.we will also classify CKD into various groups as per the KDIGO 2013.
1 day
Frequency of patients with HbA1C less than 7% in T2DM patients with and without CKD
Time Frame: 1 day
Frequency of patients with HbA1C (Glycated Haemoglobin) less than 7% in T2DM patients with and without CKD. we will correlate prevalence of CKD with HbA1C level.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Chair: Dr. Prasanna Kumar K.M, DM, Endocrinology Center for Diabetes and Endocrine Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

August 4, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Estimate)

March 25, 2016

Last Update Submitted That Met QC Criteria

March 24, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1843R00050
  • NIS-DIN-XXX-2014/1 (Other Identifier: AstraZeneca)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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